Overview
Título del trabajo: Associate Complaint Investigator – Temporary 10 months (Coyol, Alajuela)
Compañía: Smith & Nephew
Descripción de funciones: Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.Are you interested in making a global impact? This position supports the complaint investigation process. This position will perform required investigation tasks based on complaint criticality and following procedure requirements and detail the results in an electronic complaint management system.Different sources of information will be used to conduct required assessment and the results will be detailed in the complaint eQMS. The individual in this role is accountable for completing work tasks following policies and procedures.For internal use only: P1What will you be doing?Perform medical device complaint investigations, including the following:
- Continually supervise open and in process device complaint investigations.
- Support complaint investigations conducting and documenting required tasks such as: Manufacturing record review, risk documentation review, complaint history review, device specification and labeling review.
- Detail the results and conclusions in accordance with policies and procedures.
- Ensure that the depth of the investigation is commensurate with the criticality of the complaint.
- Provide detailed evidence of investigation and any conclusions established as a result of the investigation actions.
- Complete all required customer complaint investigations in an accurate, professional and timely manner.
What will you need to be successful?
- Education: Bachelor’s degree in health sciences, engineering, chemistry, biology, business administration or other related field.
- Experience: At least 1 year of experience of relevant experience is preferred, such as technical training, Quality Assurance and/or Compliance in a regulated environment.
- Languages: proficient in English language, verbal and written (advance level).
Knowledge: Regulatory knowledge of complaint handling; complaint investigation and / or quality systems (beneficial). * Basic knowledge of regulatory compliance requirements (e.g., GMP, 21 CFR 820, ISO 13485) as well as quality assurance principles and practices.
- Experience with utilization of Pilgrim, TrackWise or ETQ preferred.
- Competencies:
- Detail Oriented.
- Eager to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
- Organized.
- Excellent interpersonal & communication skills, both written and verbal, to work with a diverse network of both internal and external groups and/or individuals, locals and in an international environment, encouraging the team-work.
- Ability to interpret diverse regulations and drive/influence effective implementation.
- Able to read specifications.
- Willing to do the daily tasks with minimal direction.
- Strong feeling for Accountability.
You. Unlimited.We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about on our website.Other reasons why you will love it here!
- Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
- Work/Life Balance: Extra days off, birthday off, voluntary hours.
- Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
- Flexibility: Hybrid work model (for more professional roles), flexible schedules.
- Training: Training program, unlimited learning.
- Extra perks: employees association, and more…
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Ubicación: Alajuela
Fecha del trabajo: Wed, 02 Oct 2024 05:23:12 GMT